[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Rules and Regulations]
[Pages 30984-30985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 91F-0160]


Food Additives Permitted For Direct Addition to Food For Human 
Consumption; Polydextrose

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of polydextrose as a 
formulation aid in film coatings applied to vitamin and mineral 
supplement tablets. This action is in response to a petition filed by 
Scientific Services, Colorcon (Colorcon).

DATES: Effective June 6, 1997; written objections and requests for a 
hearing by July 7, 1997.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rosalie M. Angeles, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3107.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 31, 1991 (56 FR 24821), FDA announced that a food 
additive petition (FAP 1A4258) had been filed by Colorcon, 415 Moyer 
Blvd., West Point, PA 19486, proposing that Sec. 172.841 Polydextrose 
(21 CFR 172.841) be amended to provide for the safe use of polydextrose 
as a formulation aid (film former/adhesion promoter) in film coatings 
applied to vitamin and mineral supplement tablets.
    Film coatings are applied to tableted food supplements to mask 
taste and to facilitate both swallowing and identification. In the 
petition, data were provided by the petitioner to establish that : (1) 
Polydextrose provides substantial improvement in the adhesion of the 
coating to tableted food supplements, and (2) it considerably improves 
the stability of colored coatings. The petitioner also established that 
the optimal level of polydextrose in the coating is 25 percent. With 
the coating constituting 5 percent of the tablet, the polydextrose 
content in the final coated product would be about 1.25 percent by 
weight or a maximum of 13 milligrams (mg) per tablet. Thus, even for 
heavy users of food supplements (consuming 5 to 10 tablets per day), 
the petitioner estimates that the maximum consumption of polydextrose 
from the proposed use of the additive in vitamin and mineral 
supplements would be no more than 130 mg per person per day (Ref. 1).
    FDA concurs with the petitioner's estimates of consumer exposure to 
the additive from the petitioned use. Further, the agency finds that 
this consumption is insignificant compared to the cumulative intake of 
polydextrose from all currently regulated uses of the additive.
     Accordingly, based on its evaluation of the data in the petition 
and other relevant material, FDA concludes that the proposed food 
additive use is safe, that the additive will achieve its intended 
technical effect, and that therefore, the regulations should be amended 
as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 7, 1997, file with the Dockets Management 
Branch (address above) written objections thereto. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum dated July 31, 1996, from Z. S.Olempska-Beer, 
Division of Product Manufacture and Use, FDA, to R. M. Angeles 
concerning review of chemistry data in FAP 1A4258.

[[Page 30985]]

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).
    2. Section Sec. 172.841 is amended by revising paragraph (c) to 
read as follows:

Sec. 172.841  Polydextrose.

*  *  *  *  *
    (c) Polydextrose is used in accordance with current good 
manufacturing practices as a bulking agent, formulation aid, humectant, 
and texturizer in the following foods when standards of identity 
established under section 401 of the act do not preclude such use: 
Baked goods and baking mixes (restricted to fruit, custard, and 
pudding-filled pies; cakes; cookies; and similar baked products); 
chewing gum; confections and frostings; dressings for salads; frozen 
dairy desserts and mixes; fruit spreads; gelatins, puddings and 
fillings; hard and soft candy; peanut spread; sweet sauces, toppings, 
and syrups; film coatings on single and multiple vitamin and mineral 
supplement tablets.
*  *  *  *  *

    Dated: May 8, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-14752 Filed 6-5-97; 8:45 am]
BILLING CODE 4160-01-F